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Effects of ACT OUT! Social Issue Theater on Youth and Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04097496
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Claude McNeal Productions
Lilly Endowment, Inc.
Information provided by (Responsible Party):
Jon Agley, Indiana University

Brief Summary:
The ACT OUT! Trial is designed as a proof-of-concept, cluster, randomized, superiority trial with two parallel groups. Although the unit of measurement is student, the unit of randomization is classroom, stratified by school. For each grade, an even number of classrooms will be selected from each school; half of the selected classrooms will be randomly assigned to intervention arm, whereas the other half will be assigned to control arm. This way, sociodemographic and school-level factors will be made approximately comparable between intervention and control arms.

Condition or disease Intervention/treatment Phase
Social Competence Bullying Behavioral: Act Out! Intervention Not Applicable

Detailed Description:

This study will be an assessment of the ACT OUT! Social Issue Theater program as a universal social and emotional learning (SEL) intervention targeting social-emotional competence (SEC) and bullying in elementary, middle, and high school students. ACT OUT! is an existing program that has been performed in various forms by professionally-trained members of an acting ensemble since 1995. The present iteration consists of three distinct scenarios per grade range (elementary, middle, and high) that present age-appropriate improvisational drama illustrating issues related to SEL and bullying, including facilitated discussion with the actors, who remain in character. The program lasts approximately one hour (scenario descriptions and a fidelity checklist for SEL/bullying elements will be made available as supplemental files).

SEL curricula typically consist of manualized and/or structured classroom or multicomponent programs taking place over time; the median number of sessions within an SEL program in a meta-analysis of 213 SEL studies was 24. At one hour in duration, ACT OUT! is substantially shorter and is performed by professional actors - meeting the goal of reduced school resource costs for SEL programming, but potentially raising concerns about whether such a dose could reasonably be expected to produce an effect. Underlying this study is a supposition that unique properties of a dramatic performance specifically may trigger SEL responses. In Aristotle's Poetics, which is the first known work on dramatic theory, it is written that a dramatic tragedy (in the Aristotelian sense) is designed to arouse certain feelings, "wherewith to accomplish catharsis of… emotions." This precise mechanism underlies the development of psychodrama as a psychotherapeutic intervention, as combined action and verbalization can present a situation "freed from the restricting stereotyped residues of past experience." Recent studies and meta-analyses have examined psychodrama as a means of prevention and/or behavior change with generally positive findings. Researchers have also found that youth report that they enjoy psychodramatic elements as part of a larger prevention curriculum. However, no studies have measured any outcomes of a psychodramatic SEL experience.

This will be the first study to examine whether a short dose of interactive psychodrama can affect SEC metrics and bullying experiences in schoolchildren. In responding to recent criticism of SEL studies, the investigators have chosen to utilize the SPIRIT 2013 clinical trial guidelines in developing this protocol to promote rigor, reproducibility, and transparency.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1594 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The ACT OUT! Trial is designed as a proof-of-concept, cluster, randomized, superiority trial with two parallel groups. Randomization will be performed within clusters with a 1:1 allocation.
Masking: Single (Outcomes Assessor)
Masking Description: Because of the nature of the ACT OUT! trial, blinding of the trial participants, school officials, and members of Claude McNeal Productions is not possible. Further, since data management will occur via the primary research team, group identity cannot realistically be masked. However, we have included two statistical consultants - one internal to the university and one external to the university - who will be asked to verify all analyses using masked group assignment.
Primary Purpose: Other
Official Title: Multi-Site Cluster, Randomized Proof of Concept Trial to Study the Effects of the ACT OUT! Social Issue Theater Program on Social-Emotional Competence and Bullying in Youth and Adolescents
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: Act Out! Intervention
Eligible classrooms will be randomized to attend a 1-hour ACT OUT! interactive, semi-improvisational psychodrama performance. The ACT OUT! intervention is an established theater program ( The ACT OUT! production will include three vignettes paired with moderated discussions between the audience and the actors, the latter who will remain partly in character for the duration of the intervention. Vignettes will be different for each grade level included in the study (4th, 7th, and 10th). Public documentation of the guidelines for the ACT OUT! intervention will be made available as a supplemental file attached to the primary outcomes paper for the study.
Behavioral: Act Out! Intervention
Data included in the description of the intervention arm.

No Intervention: Control
Classrooms randomized to this arm will continue with their school day as normal, except that they will complete the data collection tools.

Primary Outcome Measures :
  1. Change from Baseline Social-Emotional Competence [ Time Frame: Separately, 2 weeks post-intervention, and 6 months post-intervention ]
    Computed from the Delaware Social Emotional Competency Scale (DSECS-S). The score is averaged from Likert-type data (e.g., one overall score will be computed from 12 questions). The score ranges from '1' to '4' - some items will be reverse coded, so that a '4' is consistently the optimal score across questions and for the total scale value.

  2. Change from Baseline Bullying Prevalence (self-report) [ Time Frame: Separately, 2 weeks post-intervention, and 6 months post-intervention ]
    Bullying activity (being bullied and bullying) via two parallel 13-item scales on the Bullying and Cyberbullying Scale for Adolescents (BCS-A). This scale captures frequency data and so is interpretable on its face (e.g., # instances of a behavior or observation).

  3. Change from Baseline Bullying Prevalence (objective) [ Time Frame: 6 months post-intervention ]
    Disciplinary referrals for bullying (aggregated, not individual)

Secondary Outcome Measures :
  1. Change from Baseline Social-Emotional Competence Sub-Domains (7th and 10th grades only) [ Time Frame: Separately, 2 weeks post-intervention, and 6 months post-intervention ]
    Social awareness, emotion regulation, relationship skills, and responsible decision-making as measured via 4 sub-scales of the Washoe County School District Social-Emotional Competency Assessment. For each sub-scale, the score is averaged from Likert-type data (e.g., one overall score will be computed from 3-5 questions). The score ranges from '1' to '4' - a '4' is consistently the optimal score across questions and for the total scale value.

  2. Receptivity to the Act Out! Intervention [ Time Frame: 2 weeks post-intervention ]
    Subjective receptivity to the intervention (e.g., enjoyment) as measured by response items from Dent et al. (1998). This scale *does not* have a specific name. It measures the following characteristics of receptivity to the intervention: whether it was enjoyable, interesting, a waste of time, boring, understandable, difficult to understand, believable, important, and helpful. Each item is measured using a Likert-type scale. The score ranges from '1' to '4' - some items will be reverse coded, so that a '4' is consistently the optimal score across questions and for the total scale value.

  3. Frequency of Truancy/Absenteeism [ Time Frame: 6 months post-intervention ]
    Data for clusters from district records (aggregated, not individual). These data already exist. No individual-level data will be utilized, only aggregated frequency of truancy/absenteeism.

  4. Academic Performance using standard Grade Point Average [ Time Frame: 6 months post-intervention ]
    Data for clusters from district records (aggregated, not individual); grade point average normalized to a 4.0 grading scale (where 4.0 is an A and 1.0 is an F).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Classrooms must be comprised of 4th grade (Elementary), 7th grade (Middle), or 10th grade (High) students

Exclusion Criteria:

  • Participants and their parents or legal guardians will review study procedures. Parents or guardians may opt out on behalf of their dependents, and participants may themselves opt out.
  • If a given grade within a school has an odd number of classrooms, one classroom randomly will be excluded from participation.

Claude McNeal Productions. Act Out Ensemble [Internet]. Claude McNeal Productions. 2019 [cited 11 September 2019]. Available from:
Rosenstein L. On Aristotle and thought in drama. Critical Inquiry. 1977;3(3):543-65.
Krahé B, Knappert L. A group-randomized evaluation of a theatre-based sexual abuse prevention programme for primary school children in Germany. J Community Appl Soc Psychol. 2009;19(4):321-9.
Sussman SY. Evaluating the efficacy of Project TND: Evidence from seven research trials. In: Scheier LM, editor. Handbook of adolescent drug use prevention: Research, intervention strategies, and practice. Washington DC: American Psychological Association; 2015. p. 159-76.
Mantz LS, Bear GC, Yang C, Harris, A. The Delaware Social-Emotional Competency Scale (DSECS-S): Evidence of validity and reliability. Child Indic Res. 2018;11(1):137-57.

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Responsible Party: Jon Agley, Associate Professor, Indiana University Identifier: NCT04097496     History of Changes
Other Study ID Numbers: 2019 0543
161999 ( Other Identifier: Indiana University )
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

All IPD that underlie results in study publications will be made available in fully de-identified form. The study protocol will be published in an open-access journal and will include the statistical analysis plan, per SPIRIT 2013 recommendations.

All forms related to recruitment and protocol execution will also be made available as supplemental files in appropriate outcome publications. The analytic code for each outcome publication will be published as a supplemental file with the corresponding paper.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Data will be made available at the time of publication.
Access Criteria: Data will be open-access.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Behavioral Symptoms